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APO-MIRABEGRON is a brand name for Mirabegron, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................. 3 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
5% of patients treated with mirabegron extended-release tablets 50 mg, mirabegron extended-release tablets 100 mg, and active control once daily, respectively. Neoplasms reported by 2 patients treated with mirabegron extended-release tablets 100 mg included breast cancer, lung neoplasm malignant and prostate cancer.
In a clinical study in Japan, a single case was reported as Stevens-Johnson syndrome with increased serum ALT, AST and bilirubin in a patient taking mirabegron extended-release tablets 100 mg as well as an herbal medication (Kyufu Gold) (see ADVERSE REACTIONS).
3%) taking mirabegron extended-release tablets 50 mg, and these markers subsequently returned to baseline while both patients continued mirabegron extended- release tablets (see ADVERSE REACTIONS).
Cardiovascular QTc Prolongation:
Mirabegron extended-release tablets was associated with dose-dependent QTc prolongation that was more pronounced in females. At the maximal recommended therapeutic dose of 50 mg, the largest mean difference from placebo in the QTc interval was <5 ms in healthy male and female subjects at steady-state (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacodynamics, Cardiac Electrophysiology and Haemodynamics).
, hypokalemia) or patients who are taking medications known to prolong the QT interval (see Drug-Drug Interactions, Drugs that Cause QT/QTc Prolongation).
Blood Pressure:
Mirabegron extended-release tablets can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with APO- MIRABEGRON, especially in hypertensive patients. Mirabegron was not studied in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) and, therefore is not recommended in these patients (see CONTRAINDICATIONS).
In a healthy volunteer study, mirabegron extended-release tablets was associated with dose-dependent increases in supine systolic/diastolic blood pressure. 7 mm Hg greater than placebo. 5 to 1 mm Hg compared to placebo. Both systolic blood pressure and diastolic blood pressure increases were reversible upon discontinuation of treatment (see ACTION AND CLINICAL PHARMACOLOGY, Cardiac Electrophysiology and Haemodynamics, Effects on Pulse Rate and Blood Pressure in Patients with OAB).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mirabegron in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Heart Rate Increase:
Mirabegron extended-release tablets is associated with increased heart APO-MIRABEGRON Product Monograph Page 5 of 43 rate that correlates with increasing dose (see ACTION AND CLINICAL PHARMACOLOGY, Cardiac Electrophysiology and Haemodynamics).
In a healthy volunteer study, Mirabegron extended-release tablets was associated with dose-dependent increases in heart rate. 5 bpm in males at steady-state. In patients with OAB in clinical trials receiving the maximum recommended dose of mirabegron extended-release tablets 50 mg, a mean heart rate increase of approximately 1 bpm compared to placebo was observed that was reversible upon discontinuation of treatment.
Accordingly, caution should be used when administering APO-MIRABEGRON to patients who have a history of ischemic heart disease or tachyarrhythmias.
Endocrine and Metabolism CYP2D6:
Since mirabegron is a moderate CYP2D6 inhibitor, the systemic exposure to CYP2D6 substrates such as metoprolol and desipramine is increased when co-administered with mirabegron (≥100 mg). Therefore, caution is advised if mirabegron is co-administered with these drugs as appropriate monitoring and dose adjustment may be necessary, especially with narrow therapeutic index drugs metabolized by CYP2D6.
The dose of APO-MIRABEGRON should not exceed 25 mg when co-administered with narrow therapeutic index drugs, such as flecainide and propafenone (see DRUG INTERACTIONS and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Genitourinary Urinary Retention:
Urinary retention has been reported in post-marketing experience in patients taking mirabegron, in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of OAB. APO-MIRABEGRON should be administered with caution to patients with clinically significant BOO.
APO-MIRABEGRON should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB (see ADVERSE REACTIONS, Post-Market Adverse Drug Reactions; ACTION AND CLINICAL PHARMACOLOGY and DRUG INTERACTIONS).
Hepatic/Biliary/Pancreatic Mirabegron extended-release tablets has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and, therefore, is not recommended for use in this patient population (see DOSAGE AND ADMINISTRATION, Dosing Consideration).
In patients with moderate hepatic impairment (Child-Pugh Class B), the daily dose of APO- MIRABEGRON should not exceed 25 mg. No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A) (see DOSAGE AND ADMINISTRATION, Dosing Consideration and ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
Immune Angioedema of the face, lips, tongue, and/or larynx has been reported with mirabegron extended- release […]